Duns Number:079628327
Device Description: Oxygen Tubing, 7 feet with Secure-Fit Connector
Catalog Number
-
Brand Name
N/A
Version/Model Number
IV-605
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
f6f3fd8e-37a2-4782-80b8-5ad636201b4e
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
00857863007666
Quantity per Package
3
Contains DI Package
00857863007581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag/Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |